FDA.reportPublic FDA data

Cathflo Activase

Product NDC
50242-041
11-digit product format
502420041
Labeler code
50242
Product ID
50242-041_0c2938dd-2978-411f-bd76-208fc8754838
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alteplase
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Genentech, Inc.
Application
BLA103172
Marketing category
BLA
Marketing start
2001-09-04
Substance
ALTEPLASE
Active strength
2.2 mg/2mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cathflo Activase
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALTEPLASE2.2 mg/2mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1RXS4UE564Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
91ecdef2-95ff-42dd-a31c-c8a09cab3ad9Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50242-041-10Cathflo Activase2 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,218
50242-041-10Cathflo Activase10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,1018
50242-041-64Cathflo Activase1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,118
50242-041-64Cathflo Activase2 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,218

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50242-041-10EA - Each50242-041e8ce1611-5211-4706-8a36-acee67fb608512019-11-12
50242-041-64EA - Each50242-041bf0baa6d-43ee-4799-b2fe-1a6209a9d87512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALTEPLASEACTIVE INGREDIENT1RXS4UE564CATHFLO ACTIVASE (ALTEPLASE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENENTECH, INC.]3
ALTEPLASEACTIVE MOIETY1RXS4UE564CATHFLO ACTIVASE (ALTEPLASE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENENTECH, INC.]3
ARGININEINACTIVE INGREDIENT94ZLA3W45FCATHFLO ACTIVASE (ALTEPLASE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENENTECH, INC.]3
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NNCATHFLO ACTIVASE (ALTEPLASE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENENTECH, INC.]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCATHFLO ACTIVASE (ALTEPLASE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENENTECH, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50242-041CATHFLO ACTIVASE (ALTEPLASE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENENTECH, INC.]15Current NDC, Legacy NDC, 4 package rows20241206_91ecdef2-95ff-42dd-a31c-c8a09cab3ad9.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cathflo ActivaseALTEPLASEGenentech, Inc.91ecdef2-95ff-42dd-a31c-c8a09cab3ad92026-01-20Warnings, Adverse reactionsExact identifier
application number: BLA103172
ndc (product): 50242-041
ActivaseALTEPLASEGenentech, Inc.c669f77c-fa48-478b-a14b-80b20a0139c22026-01-20Warnings, Adverse reactionsExact identifier
application number: BLA103172

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103172Activasealteplase351(a)Rx2026-07-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50242-041-105024200411010 VIAL in 1 CARTON (50242-041-10) / 2 mL in 1 VIAL10 vial2019-10-140000-00-00NoNoCurrent
50242-041-64502420041641 VIAL in 1 CARTON (50242-041-64) / 2 mL in 1 VIAL1 vial2001-09-040000-00-00NoNoCurrent